Predicting Sleep, Smoking, and Lung Health Disparities in African American Adults

Active, not recruiting

• Conditions: Lung Diseases; Sleep; Smoking

• Registration Number: NCT03534076
• Lead Sponsor: Temple University

Brief Summary

This 5-year prospective, observational study will: (1) determine the individual, social, and environmental predictors of sleep duration, quality, latency, efficiency, timing and regularity in African American smokers, (2) quantify the prospective relationship between multiple metrics of sleep with tobacco use, such that a sleep phenotype of risk for smoking is defined, and (3) examine the extent to which short sleep (\<7 hrs) and other unhealthy sleep metrics, predicts lung function through smoking behaviors and inflammation, in 480 African Americans at risk for advancing COPD (GOLD Stage 0-2 and current smoker). Study subjects will be recruited via Temple Health System sites. Following eligibility screening, initially eligible subjects will provide written study consent and complete an in-home sleep assessment to rule out the exclusionary moderate-severe sleep apnea and other sleep disorders. Consenting and eligible subjects will be entered into the study and across the 60-month data collection period, complete 8 assessments: 4 annual clinical based assessments, interspersed by 4 mid-year, phone-based, self-report assessments.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-05-11
• Study First Posted: 2018-05-23
• Study Start: 2018-06-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-19
• Last Update Posted: 2023-09-21
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 303

Inclusion Criteria

1. Self-reported African American, White, or mixed ethnicity.
2. 40 - 67 years.
3. GOLD stage 0-3 as assessed by spirometry.
4. No moderate-severe sleep disorders or use of sleep medication.
5. Self-reported current cigarette smoker as defined by smoking one or more cigarettes in the last month.
6. Able to communicate in English and provide written informed consent.

Exclusion Criteria

1. Self-reported ethnicity (in full or part) other than Black/African American or White.
2. < 40 years of age.
3. Not a current cigarette smoker (< 1 cigarette in last month).
4. GOLD stage >3.
5. Presents with a diagnosed moderate-severe sleep disorder
6. Use of any sleep medication. -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FEV1/FVC ratio	365 days	Lung function as defined as the ratio of Forced Expiration Volume in one second (FEV1) to the Forced Vital Capacity (FVC; FEV1/FVC ratio) will be computed

Trial Locations

Locations (1)

Temple University Health System; 🇺🇸 Philadelphia, Pennsylvania, United States